Breast CancerLETTERNCT01069211
Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women
An observational study of Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 876 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients recruited into the study are postmenopausal women with estrogen receptor positive breast cancer.
Who may be able to join
- Patients with estrogen receptor(+) and/or progesterone receptor(+)
- Postmenopausal state was defined the following conditions, at least one of a, b
- Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years
- Bilateral oophorectomy
- Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
- WHO(ECOG) performance status 0-2
- Adequate haematological function, renal function, hepatic function.
- No evidence of metastasis.
Who cannot join
- Metachronous bilateral breast cancer.
- Metastatic breast cancer (stage IV)
- Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
- Patients with Child-Pugh grade C, serum creatinine>2xUNL
- Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Joon Jeong
Seoul
Joon Jeong, MD, 82-2-2019 - 3300, gsjjoon@yumc.yonsei.ac.kr
About this study
Official title: Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.
Read the detailed description
This study aimed at evaluating following:
- Validity Assessment:
- Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole treatment according to the estrogen receptor expression in postmenopausal women
- Secondary End Point: To evaluate overall survival rate(OS) and Time to distance recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone receptor positive breast cancer
- Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Letrozole, postmenopause, hormone receptor positive breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ER expression : Low | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score. | |
| ER expression : Intermediate | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score. | |
| ER expression : High | Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: the first 5 years after enrollment
Secondary outcomes (3)
Adverse effect
Measured: the first 5 years after enrollment
Overall Survival
Measured: the first 5 years after enrollment
Time to Distant Recurrence (TTDR)
Measured: the first 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 876 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Joon Jeong, MD, Principal investigator, Department of Surgery, Gangnam Severance Hospital, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069211
- Sponsor's protocol ID
- KBCSG006
- Acronym
- LETTER
- Status last verified
- May 2011
- First submitted
- 14 Feb 2010
- Last updated
- 11 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahn SG, Nam SJ, Ahn SH, Jung Y, Park HK, Lee SJ, Kang SS, Han W, Park KH, Park YL, Lee J, Youn HJ, Kim JH, Yoo Y, Song JY, Ko BK, Gwak G, Chung MS, Kim SY, Cho SH, Kim D, Chang MC, Moon BI, Kim LS, Kim SJ, Park MH, Kim TH, Cho J, Lim CW, Bae YT, Gong G, Bae YK, Lee A, Jeong J. Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006). J Breast Cancer. 2021 Apr;24(2):164-174. doi: 10.4048/jbc.2021.24.e17. Epub 2021 Mar 25.
PubMed 33818022
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT01069211
- Acronym / sponsor ID
- LETTER / KBCSG006
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Letrozole, postmenopause, hormone receptor positive breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 876 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 17 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.
Detailed description
This study aimed at evaluating following:
- Validity Assessment:
- Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole treatment according to the estrogen receptor expression in postmenopausal women
- Secondary End Point: To evaluate overall survival rate(OS) and Time to distance recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone receptor positive breast cancer
- Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ER expression : Low | – | –Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score. |
| ER expression : Intermediate | – | –Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score. |
| ER expression : High | – | –Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recruited into the study are postmenopausal women with estrogen receptor positive breast cancer.
Key inclusion criteria (8 listed)
- Patients with estrogen receptor(+) and/or progesterone receptor(+)
- Postmenopausal state was defined the following conditions, at least one of a, b
- Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks.
- WHO(ECOG) performance status 0-2
- Adequate haematological function, renal function, hepatic function.
Key exclusion criteria (5 listed)
- Metachronous bilateral breast cancer.
- Metastatic breast cancer (stage IV)
- Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream.
- Patients with Child-Pugh grade C, serum creatinine>2xUNL
- Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease free survival
Time frame: the first 5 years after enrollment
3 secondary outcomes
Adverse effect
Time frame: the first 5 years after enrollment
Overall Survival
Time frame: the first 5 years after enrollment
Time to Distant Recurrence (TTDR)
Time frame: the first 5 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
- Derived from this study: PubMed 33818022Ahn SG, Nam SJ, Ahn SH, Jung Y, Park HK, Lee SJ, Kang SS, Han W, Park KH, Park YL, Lee J, Youn HJ, Kim JH, Yoo Y, Song JY, Ko BK, Gwak G, Chung MS, Kim SY, Cho SH, Kim D, Chang MC, Moon BI, Kim LS, Kim SJ, Park MH, Kim TH, Cho J, Lim CW, Bae YT, Gong G, Bae YK, Lee A, Jeong J. Clinical Outcomes Following Letrozole Treatment according to Estrogen Receptor Expression in Postmenopausal Women: LETTER Study (KBCSG-006). J Breast Cancer. 2021 Apr;24(2):164-174. doi: 10.4048/jbc.2021.24.e17. Epub 2021 Mar 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joon Jeong, MD principal investigator
Department of Surgery, Gangnam Severance Hospital, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ku Sang Kim, MD (82-31-219-5200, ideakims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: the first 5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01069211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2011.